Ignite Creation Date:
2024-05-05 @ 9:53 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003621
Status:
COMPLETED
Last Update Posted:
2016-07-14
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Anaplastic Astrocytoma
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Phase II Trial of Pre-Irradiation Chemotherapy With BCNU Cisplatin and Oral Etoposide Combined With Radiation Therapy in the Treatment of Grade 3 Astrocytoma Anaplastic Astrocytoma
Status:
COMPLETED
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Radiation therapy uses high-energy x-rays to damage tumor cells Combining more than one drug with radiation therapy may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have newly diagnosed anaplastic astrocytoma
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have newly diagnosed anaplastic astrocytoma
Detailed Description:
OBJECTIVES I Determine the efficacy of carmustine cisplatin and etoposide given prior to and during radiotherapy in patients with anaplastic astrocytoma II Assess the toxic effects associated with this regimen in these patients III Evaluate this regimen in terms of fatigue depression excessive daytime somnolence and quality of life in these patients
OUTLINE Patients receive carmustine IV over 1 hour on days 1-3 oral etoposide on days 1-21 and 29-49 and cisplatin IV over 1-2 hours on days 1-3 and 29-31 Treatment repeats every 8 weeks for 3 courses Patients receive radiotherapy concurrently with the third course of chemotherapy Quality of life is assessed every 4 months for 1 year every 6 months for 4 years and then annually for 5 years Patients are followed every 3 months for 5 years and then annually thereafter
PROJECTED ACCRUAL A total of 28 patients will be accrued for this study within 20 months
OUTLINE Patients receive carmustine IV over 1 hour on days 1-3 oral etoposide on days 1-21 and 29-49 and cisplatin IV over 1-2 hours on days 1-3 and 29-31 Treatment repeats every 8 weeks for 3 courses Patients receive radiotherapy concurrently with the third course of chemotherapy Quality of life is assessed every 4 months for 1 year every 6 months for 4 years and then annually for 5 years Patients are followed every 3 months for 5 years and then annually thereafter
PROJECTED ACCRUAL A total of 28 patients will be accrued for this study within 20 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000066700 | REGISTRY | PDQ Physician Data Query | None |